MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM; SURGICAL SEALANT

Catalog Number CLR602

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 04/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that the patient underwent a c-section procedure on (b)(6) 2016 and topical skin adhesive was used after a closure of the incision.During the procedure, the surgeon waited over two minutes for the topical skin adhesive to dry and after initial inspection it looked good.Later, after the procedure, it was reported that the topical skin adhesive adhered itself to the skin which had folded over the incision.This only happened on the left side of the incision which was also a side the patient was rolled onto when being moved off the table.When the nurse tried to remove the topical skin adhesive from the skin fold, it placed tension on the incision creating minor bleeding.Once the part that adhered to the skin fold had been removed, the topical skin adhesive was no longer covering the whole incision and a new comfeel dressing was applied over the top.The doctor opined that the topical skin adhesive obviously not fully dried even after waiting for two minutes.Additional information has been requested.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: ken clark ; route 22 west po box 151west p; o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5652881
• MDR Text Key: 45116976
• Report Number: 2210968-2016-08928
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2016
• Initial Date FDA Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention